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Behavioral Intervention

Early Physical Therapy for Lockjaw (PRECISE Trial)

N/A

Waitlist Available

Led By Margaret McNeely, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of oral, oropharyngeal, or nasopharyngeal cancer

Be older than 18 years old

Must not have

Previous surgery for the temporomandibular joint not related to the HNC diagnosis

Local cancer recurrence or metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study ways to help individuals with head and neck cancer who experience restricted jaw movement. They will conduct a small study with 30 participants undergoing radiation therapy, comparing usual care with a new

Who is the study for?

This trial is for individuals with head and neck cancer who are about to undergo radiation therapy. They should be new patients at the HNC clinic and willing to participate in a study that could involve additional physical therapy.

What is being tested?

The trial is testing whether early physical therapy can help prevent or reduce trismus (lockjaw) compared to usual care, which involves exercises and referral for physical therapy only after trismus is detected.

What are the potential side effects?

Since this intervention includes supportive care like manual therapy and jaw exercises, side effects may include discomfort or pain from the exercises, fatigue of the jaw muscles, or soreness from manual therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with cancer in my mouth, throat, or the upper part of my throat behind the nose.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I had surgery on my jaw joint not related to head or neck cancer.

Select...

My cancer has returned or spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility: completion rate

Secondary study objectives

Cervical range of motion

Feasibility: adherence rate

Feasibility: recruitment rate

+5 more

Side effects data

From 2023 Phase 1 & 2 trial • 28 Patients • NCT04345601

100%

Anemia

70%

Blood bicarbonate decreased

70%

Hypophosphatemia

60%

Alanine aminotransferase increased

60%

Aspartate aminotransferase increased

60%

Fever

50%

Hypokalemia

50%

Platelet count decreased

50%

Blood bilirubin increased

50%

Hypocalcemia

50%

Hyperphosphatemia

40%

Hypernatremia

40%

Creatinine increased

30%

Hyponatremia

30%

Respiratory, thoracic and mediastinal disorders - Other, specify:Hypercapnia

30%

Hypercalcemia

30%

Hypoalbuminemia

30%

White blood cell decreased

20%

Hypoxia

20%

Constipation

20%

Lymphocyte count decreased

20%

Anxiety

20%

Hyperkalemia

20%

Headache

10%

Depression

10%

Cardiac arrest

10%

Epistaxis

10%

Urinary tract infection

10%

CPK increased

10%

Sepsis

10%

Anorexia

10%

Rash maculo-papular

10%

Diarrhea

10%

Fall

10%

Delirium

10%

Abdominal pain

10%

Cardiac troponin I increased

10%

Hypermagnesemia

10%

Nausea

10%

Seizure

10%

INR increased

10%

Eosinophilia

10%

Febrile neutropenia

10%

Hypertension

10%

Hypotension

10%

Lung infection

10%

Ileus

10%

Confusion

10%

Activated partial thromboplastin time prolonged

10%

Fatigue

10%

Multi-organ failure

10%

Rectal hemorrhage

10%

Neutrophil count decreased

10%

Skin and subcutaneous tissue disorders - Other, specify:rash - unspecified

10%

Pneumothorax

10%

Acute kidney injury

10%

Peripheral sensory neuropathy

10%

Hypothermia

10%

Fungemia

10%

Hematoma

100%

80%

60%

40%

20%

Study treatment Arm

Mesenchymal Stromal Cells (MSCs)

Control Group

Safety Run In

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prospective Surveillance for Trismus and Early Physical Therapy InterventionExperimental Treatment1 Intervention

Weekly monitoring of mouth opening and jaw function. Early intervention if the participant presents with 5% or greater reduction in mouth opening compared to pre-treatment measures. Early intervention will comprise: physical therapy, home exercises and use of a jaw stretching device.

Group II: Usual CareActive Control1 Intervention

Home exercise instruction and referral to physical therapy if trismus develops.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Supportive Care

2013

Completed Phase 2

~1710

0 / 3Eligibility criteria met